Benzodiazepines and the FMD
The black market for NHS drugs
One of the many problems facing the NHS today is the widespread distribution of prescription drugs outside the legal supply chain. One particular set of drugs falls under the umbrella term of Benzodiazepines, such as Diazepam (Valium) and Nitrazepam. Benzodiazepines are psychoactive drugs, often described as minor tranquilisers, and typically prescribed to reduce symptoms such as anxiety and insomnia.
The concern with prescribing Benzodiazepines is their potential for addiction and abuse. Since Benzodiazepines are very effective in their ability to reduce symptoms, there is a danger of becoming dependent on these drugs. In addition, long-term users tend to develop a tolerance, whereby they need to take an ever-growing number of pills to sustain the original therapeutic effects. This mixture of dependence and tolerance can increase the risk of overdose, a risk with severe consequences when combined with other drugs like alcohol and opiates. Withdrawal effects can often be traumatic, particularly if the Benzodiazepines have been used as sleeping pills over a long period of time.
In January 2018 BBC Radio’s File on 4 broadcast a programme documenting the dangers of prescription drugs like Benzodiazepines and how these have contributed to 3,744 drug-related deaths in England and Wales in 2016. Whilst some of the problems stem from the fact that much of these Benzodiazepines are fake and produced in back streets under crude conditions, a more troubling issue is how drugs originally intended for the NHS are being sold on the black market.
The Medicines and Healthcare Products Regulatory Agency (MHRA) report into criminality inside the regulated supply chain stated that there are around twenty investigations covering the UK. 71 people are potentially involved, including eighteen pharmacists, eleven doctors, 62 companies, and 50 pharmacies. The MHRA believe that there has been an industrial-scale diversion of Benzodiazepines and related prescription-only medicines from the legitimate supply line, to the street or via the internet. Estimates suggest that about 160 million tablets have been diverted over three years with a value of up to £200 million.
Such problems were initially identified in the Republic of Ireland. The Medicines Regulator seized a supply of medication that consisting of UK-regulated supply chain drugs, packaged for the UK market. Similar products destined for the criminal market were also found in Scotland around the same time. The most concerning issue here is how these regulated drugs found their way onto the black market. Worryingly, it appears that wholesale dealers and pharmacists have been ordering vast amounts of prescription drugs on behalf of criminals, who then sell these through illegitimate sources.
Some wholesalers perhaps do this unknowingly, selling medication to sources that use fake licensing documentation, but there is clear evidence of deliberate delinquency in many cases. The quantities of Benzodiazepines required by a pharmacist for regular prescriptions are relatively small yet shipments have been made many times in excess of the expected demand. Sales have been made to customers whose credentials appear authentic but who have agreed to pick up the drugs from the supplier in their own transport and have paid on collection in cash.
Pharmacists are also heavily implicated, involved in 90% of the MHRA’s investigations. This is perhaps the greatest concern, that people working in a position of such responsibility and trust would actively collaborate with criminals, knowing full well the consequences of their actions. The cash incentive to look the other way is strong. A box of tablets that might cost £1-2 to the pharmacist could be sold on the street or on-line for £30. The original regulated packaging is usually discarded and the drugs sold by foil inner or even on a pill by pill basis.
This is not a victimless crime. Dosages are not being regulated by prescription. When an offending distributor is tracked down the directors of that company will be held personally responsible for the fraud. They will be liable for any fines or penalties, not the company that they represent.The FMD comes into force from 9 February 2019 and will ensure that all prescription drug packets originating from the UK, EU and the EFTA need to be marked with a unique identification code. This consists of a product code, batch number, expiry date and serial number together with a tamper-proof seal indicating that the contents have not been compromised. If the original outer packaging has been destroyed there is no guarantee that the drugs came from an authorised manufacturer nor that the dose or formulation present is as it should be.
Although it would appear that without a tamper proof outer there is no way that the FMD regulation can help there may be a way that the new verification system can provide clues. If the drugs are seized in their original packs or the discarded packs are found the unique identification codes for each pack are known. Each time a code is scanned the purpose of the scan and the scanning body is recorded. A search of existing records will show who last scanned the products and when. This scanner may not have broken any laws but will indicate the last known legitimate action in the supply chain. The source can be approached and investigated as to how they disposed of the product. This information will lead the investigators one step closer to the point where the drugs were illegally disposed of. There may still be a chain to follow to find exactly how the drugs passed to the street market but the unique code would give a place to start.
It is most likely that street drugs will be recovered with no packing and no easy way to relate their source to the FMD governed supply chain. Legitimate records will, however, report on the quantities of drugs entering the market and when these drugs were dispensed. The discrepancy between new codes being printed and those same codes being dispensed will give an indication of the quantity of drugs not being dispensed through the FMD supply chain. The volume of traffic at points of verification will also give a clue to suspect behaviour. Suspiciously high or low volumes of traffic at specific scanning points might indicate an unrealistic volume of drugs being supplied or drugs being supplied but not verified as they arrive at their destination. These checks could be run at a product or batch level enabling traffic from a specific packer to be traced.
To conclude the FMD legislation is not designed to track and trace but can be seen to have some incidental benefit to supply chain fraud even when the original packing is lost.
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